Younes Maged, Aggett Peter, Aguilar Fernando, Crebelli Riccardo, Dusemund Birgit, Filipič Metka, Frutos Maria Jose, Galtier Pierre, Gundert-Remy Ursula, Kuhnle Gunter Georg, Lambré Claude, Leblanc Jean-Charles, Lillegaard Inger Therese, Moldeus Peter, Mortensen Alicja, Oskarsson Agneta, Stankovic Ivan, Waalkens-Berendsen Ine, Woutersen Rudolf Antonius, Wright Matthew, Tobback Paul, Rincon Ana Maria, Smeraldi Camilla, Gott David
EFSA J. 2018 Feb 21;16(2):e05181. doi: 10.2903/j.efsa.2018.5181. eCollection 2018 Feb.
The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on the safety of glucosylated steviol glycosides proposed for use as a new food additive in different food categories. According to the applicant, glucosylated steviol glycosides preparations consist of not less than 95% (on anhydrous basis) total steviol glycosides, made up of glucosylated steviol glycosides of different molecular weights as well as any remaining steviol glycosides. The applicant proposed that glucosylated steviol glycosides and parent steviol glycosides undergo a common metabolic process in pathway following ingestion and suggested that data from steviol glycosides can be used for read-across to glucosylated steviol glycosides. The limited evidence provided in the application dossier did not demonstrate the complete hydrolysis of the glucosylated steviol glycosides. No toxicological studies on glucosylated steviol glycoside preparations under evaluation have been provided for its assessment. The Panel concluded that the submitted data are insufficient to assess the safety of the glucosylated steviol glycoside preparations to be used as a new food additive.
欧洲食品安全局食品添加剂和添加到食品中的营养源专家委员会(ANS)就拟用作不同食品类别中新食品添加剂的葡萄糖基化甜菊糖苷的安全性提供了科学意见。根据申请人所述,葡萄糖基化甜菊糖苷制剂包含不少于95%(无水基)的总甜菊糖苷,由不同分子量的葡萄糖基化甜菊糖苷以及任何剩余的甜菊糖苷组成。申请人提出,葡萄糖基化甜菊糖苷和亲本甜菊糖苷在摄入后会经历共同的代谢过程,并建议甜菊糖苷的数据可用于类推葡萄糖基化甜菊糖苷。申请文件中提供的有限证据并未证明葡萄糖基化甜菊糖苷的完全水解。未提供正在评估的葡萄糖基化甜菊糖苷制剂的毒理学研究以供评估。专家委员会得出结论,所提交的数据不足以评估用作新食品添加剂的葡萄糖基化甜菊糖苷制剂的安全性。